Korean Red Ginseng Rg3 Extract on Arterial Stiffness and Blood Pressure

NCT ID: NCT01951443

Last Updated: 2014-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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The purpose of the study is to evaluate the acute effect of a standardized extract of KRG (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial stiffness and blood pressure, as measured by the following parameters: aortic augmentation index, peripheral blood pressure, central blood pressure

Detailed Description

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Conditions

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Arterial Stiffness, Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ginseng

Encapsulated 400mg Rg3-KRG extract

Group Type EXPERIMENTAL

Ginseng

Intervention Type DIETARY_SUPPLEMENT

400mg of encapsulated Rg3-KRG

Wheat Bran

400mg Wheat Bran capsule

Group Type PLACEBO_COMPARATOR

Wheat Bran

Intervention Type DIETARY_SUPPLEMENT

400mg of encapsulated wheat bran

Interventions

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Ginseng

400mg of encapsulated Rg3-KRG

Intervention Type DIETARY_SUPPLEMENT

Wheat Bran

400mg of encapsulated wheat bran

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Age 18-70 years
* BMI \< 30 kg/m2
* Brachial systolic blood pressure \< 140 mmHg
* Brachial diastolic blood pressure \< 90 mmHg

Exclusion Criteria

* BMI \>30kg/m2
* Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Vladimir Vuksan, PhD

Role: PRINCIPAL_INVESTIGATOR

Risk Factor Modification Centre - St. Michael's Hospital

Dr. Amir Hanna (Qualified investigator), MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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KRAB

Identifier Type: -

Identifier Source: org_study_id

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